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Natrelle Breast Implants recallZ-2452-2019 · Allergan PLC · initiated Jul 24, 2019

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Allergan PLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

UPDATE: On June 1, 2020, Allergan issued a press release outlining a dedicated multi-channel campaign to contact women who may not be aware of the Biocell recall and to improve tracking information for U. S. Breast Implant patients (link: https://news.abbvie.com/news/press-releases/allergan-aesthetics-launches-dedicated-multi-channel-campaign-to-contact-patients-who-may-not-be-aware-biocell-recall-and-to-improve-tracking-information-for-us-breast-implant-patients.htm) On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). Recall letters were sent on August 6, 2019 via: FedEx overnight mail with tracking to all consignees who may have product within expiry. The recall letter will inform customers to do the following: 1. If you have inventory of the recalled products, Quarantine product to prevent its use. 2. Conduct a physical count of the affected products in your possession and record the count on the enclosed Recall Stock Response Form. 3. Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. 4. Upon receipt of the Response Form, Inmar will issue Return Authorization label(s). 5. When returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to: Inmar Rx Solutions, Inc. 4332 Empire Rd. Fort Worth, TX 76155 6. Please Do Not return any products that are not the subject of this recall. Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions. Patient letters were mailed on August 14, 19 and 26, 2019 to all impacted patients to which Allergan had complete names and addresses in their device tracking database. The patient letters informed customers of the following: 1. How

Recall details

Recall number
Z-2452-2019
Status
Open, Classified
Initiated by the company
Jul 24, 2019
Posted by the FDA
Sep 11, 2019
Recalling firm
Allergan PLC
Quantity
4,026,287 Breast Implants and Tissue Expanders Combined in total
Product code
FTR
FDA submissions
P040046
Distribution
Worldwide Distribution and US Nationwide All fifty (50) US States, the US Virgin Islands and Puerto Rico. (AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY). OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam.

Product description

Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM-410320; Style LF: LF-410125, LF-410150,LF-410175,LF-410205,LF-410240,LF-410270,LF-410310,LF-410390,LF-410440,LF-410490,LF-410540,LF-410595,LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; style LX: LX-410145,LX-410175,LX-410195,LX-410225,LX-410255,LX-410290,LX-410330,LX-410365,LX-410405,LX-410455,LX-410515,LX-410570,LX-410625; Style ML: ML-410125,ML-410170,ML-410195,ML-410220,ML-410285; Style MM: MM-410160,MM-410185,MM-410215,MM-410245,MM-410280,MM-410320,MM-410360,MM-410400,MM-410450; Style MF: MF-410140MF-410165,MF-410195,MF-410225,MF-410255,MF-410295,MF-410335,MF-410375,MF-410420,MF-410470,MF-410525,MF-410580,MF-410640; Style MX: MX-410165,MX-410195,MX-410225,MX-410255,MX-410290,MX-410325,MX-410370,MX-410410,MX-410445,MX-410520,MX-410550,MX-410620,MX-410685; Style FL: FL-410140,FL-410190,FL-410220,FL-410250,FL-410320; Style FM:FM-410155,FM-410180,FM-410205,FM-410235,FM-410270,FM-410310,FM-410350,FM-410395,FM-410440,FM-410500,FM-410550,FM-410605,FM-410670; Style FF: FF-410160,FF-410185,FF-410220,FF-410255,FX-410290,FF-410335,FF-410375,FF-410425,FF-410475,FF-410535,FF-410595,FF-410655,FF-410740; Style FX: FX-410185FX-410215,FX-410245,FX-410280,FX-410315,FX-410360,FX-410410,FX-410450,FX-410495,FX-410560,FX-410615,FX-410690,FX-410775 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

ALL LOTS   Product Code/UDI  Style LL: LL-410135/10888628003170,LL-410180/10888628003187,LL-410210/10888628003194,LL-410240/10888628003200,LL-410300/10888628003217; Style LM: LM-410140/10888628003224,LM-410190/10888628003231,LM-410220/10888628003248,LM-410250/10888628003255,LM-410320/10888628003262; Style LF: LF-410125/10888628003057,LF-410150/10888628003064,LF-410175/10888628003071,LF-410205/10888628003088,LF-410240/10888628003095,LF-410270/10888628003101,LF-410310/10888628003118,LF-410390/10888628003125,LF-410440/10888628003132,LF-410490/10888628003149,LF-410540/10888628003156,LF-410595/10888628003163; Style LX: LX-410145/10888628003279,LX-410175/10888628003286,LX-410195/10888628003293,LX-410225/10888628003309,LX-410255/10888628003316,LX-410290/10888628003323,LX-410330/10888628003330,LX-410365/10888628003347,LX-410405/10888628003354,LX-410455/10888628003361,LX-410515/10888628003378,LX-410570/10888628003385,LX-410625/10888628003392; Style ML: ML-410125/10888628003538,ML-410170/10888628003545,ML-410195/10888628003552,ML-410220/10888628003569,ML-410285/10888628003576; Style MM: MM-410160 10888628003583,MM-410185/10888628003590,MM-410215/10888628003606,MM-410245/10888628003613,MM-410280/10888628003620,MM-410320/10888628003637,MM-410360/10888628003644,MM-410400/10888628003651,MM-410450/10888628003668; Style MF:MF-410140/10888628003408,MF-410165/10888628003415,MF-410195/10888628003422,MF-410225/10888628003439,MF-410255/10888628003446,MF-410295/10888628003453,MF-410335/10888628003460,MF-410375/10888628003477,MF-410420/10888628003484,MF-410470/10888628003491,MF-410525/10888628003507,MF-410580/10888628003514,MF-410640/10888628003521; Style MX:MX-410165/10888628003675,MX-410195/10888628003682,MX-410225/10888628003699,MX-410255/10888628003705,MX-410290/10888628003712,MX-410325/10888628003729,MX-410370/10888628003736,MX-410410/10888628003743,MX-410445/10888628003750,MX-410520/10888628003767,MX-410550/10888628003774,MX-410620/10888628003781,MX-410685/10888628003798;  Style FL: FL-410140/10888628002746,FL-410190/10888628002753,FL-410220/10888628002760,FL-410250/10888628002777,FL-410320/10888628002784; Style FM:FM-410155/10888628002791,FM-410180/10888628002807,FM-410205/10888628002814,FM-410235/10888628002821,FM-410270/10888628002838,FM-410310/10888628002845,FM-410350/10888628002852,FM-410395/10888628002869,FM-410440/10888628002876,FM-410500/10888628002883,FM-410550/10888628002890,FM-410605/10888628002906,FM-410670/10888628002913; Style FF: FF-410160/10888628002616,FF-410185/10888628002623,FF-410220/10888628002630,FF-410255/10888628002647,FF-410290/10888628002654,FF-410335/10888628002661,FF-410375/10888628002678,FF-410425/10888628002685,FF-410475/10888628002692,FF-410535/10888628002708,FF-410595/10888628002715,FF-410655/10888628002722,FF-410740/10888628002739;  Style FX: FX-410185/10888628002920,FX-410215/10888628002937,FX-410245/10888628002944,FX-410280/10888628002951,FX-410315/10888628002968,FX-410360/10888628002975,FX-410410/10888628002982,FX-410450/10888628002999,FX-410495/10888628003002,FX-410560/10888628003019,FX-410615/10888628003026,FX-410690/10888628003033,FX-410775/10888628003040;

Devices named in this recall

118 devices in the FDA device registry whose identifier appears in the recall's code information; the 100 most reported are shown.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 83500).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page